NCT07289243

Brief Summary

THIS STUDY IS A RANDOMIZED CLINICAL TRIAL COMPARING TRANSURETHRAL PROSTATE RESECTION (TURP) AND ECHOLASER SORACTELITE-TPLA (TRANSPERINEAL LASER ABLATION) IN PATIENTS WITH LOWER URINARY TRACT SYMPTOMS DUE TO BENIGN PROSTATIC OBSTRUCTION. THE PRIMARY GOAL IS TO SHOW THE NON-INFERIORITY OF TPLA VERSUS TURP BY IPSS-SCORE.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
8mo left

Started Jul 2024

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress74%
Jul 2024Dec 2026

Study Start

First participant enrolled

July 14, 2024

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

December 4, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 17, 2025

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 25, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 25, 2026

Expected
Last Updated

December 17, 2025

Status Verified

December 1, 2025

Enrollment Period

1.4 years

First QC Date

December 4, 2025

Last Update Submit

December 4, 2025

Conditions

RANDOMIZED

Outcome Measures

Primary Outcomes (1)

  • IS TO SHOW THE NON-INFERIORITY OF TPLA VERSUS TURP BY IPSS-SCORE

    one, three, six, twelve mounth after treatment

Secondary Outcomes (2)

  • COMPARE Q-MAX UROFLOW

    one, three, six, twelve mounth after treatment

  • COMPARE INPATIENT-TIMING

    one, three, six, twelve mounth after treatment

Study Arms (2)

TPLA

OTHER

Patients underwent TPLA tretment

Procedure: ECHOLASER-TPLA

TURP

OTHER

Patients underwent TURP tretment

Procedure: TURP

Interventions

TURPPROCEDURE

Transurethral resection of prostate, by uretrocistoscopy approach.

TURP
ECHOLASER-TPLAPROCEDURE

transperineal laser ablation of prostatic adenoma, by transrectal ultrasound guide.

Also known as: TPLA
TPLA

Eligibility Criteria

Age40 Years - 85 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsMale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age, Lower urinary tract simptoms (IPSS \>= 8), uncompliance or no achived drugs treatment for IPB, prostate volume 40ml-80ml , ability to express informed consent.

You may not qualify if:

  • previous surgical tretment for IPB, bladder catheter, bladder stones, urinary or seminal infections, hypo-/a-contractilitis of bladder, bladder tuomrs, urethral stricture, neurological bladder, refuse to sign informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

UOC Urologia e Trapianti di Rene Policlinico di Bari

Bari, ITALY/Bari, 70124, Italy

RECRUITING

UOC Urologia e Trapianti di Rene Policlinico di Bari

Bari, ITALY/Bari, 70124, Italy

ACTIVE NOT RECRUITING

MeSH Terms

Interventions

Transurethral Resection of Prostate

Intervention Hierarchy (Ancestors)

ProstatectomyUrologic Surgical Procedures, MaleUrologic Surgical ProceduresUrogenital Surgical ProceduresSurgical Procedures, Operative

Central Study Contacts

Marcello MZ Zingarelli, medicine and surgery

CONTACT

+393405135446marcellozingarelli86@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

December 4, 2025

First Posted

December 17, 2025

Study Start

July 14, 2024

Primary Completion

December 25, 2025

Study Completion (Estimated)

December 25, 2026

Last Updated

December 17, 2025

Record last verified: 2025-12

Locations

IT(2)